← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

POK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Assist users in characterizing lesions identified on acquired medical images

DEVICE CLASS
Class II
REGULATION
21 CFR 892.2060
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
12
510(K)/PMA CLEARANCES
510k: 12
0
RECALL ENTRIES

Recent clearances

K253884Koios Medical, Inc. · 510k2026-07-02
K261519Sonio · 510k2026-06-04
K254161GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 510k2026-03-27
K251769Precision Medical Ventures, Inc. Dba Revealdx · 510k2026-01-30
K252294Brightheart · 510k2025-12-08
K250221Circle Cardiovascular Imaging, Inc. · 510k2025-07-01
K251071Brightheart · 510k2025-05-02
K243614Sonio · 510k2025-02-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →